Pediatric evaluations for deep learning CT denoising.

BACKGROUND: Deep learning (DL) CT denoising models have the potential to improve image quality for lower radiation dose exams. These models are generally trained with large quantities of adult patient image data. However, CT, and increasingly DL denoising methods, are used in both adult and pediatric populations. Pediatric body habitus and size can differ significantly from adults and vary dramatically from newborns to adolescents. Ensuring that pediatric subgroups of different body sizes are not disadvantaged by DL methods requires evaluations capable of assessing performance in each subgroup. PURPOSE: To assess DL CT denoising in pediatric and adult-sized patients, we built a framework of computer simulated image quality (IQ) control phantoms and evaluation methodology. METHODS: The computer simulated IQ phantoms in the framework featured pediatric-sized versions of standard CatPhan 600 and MITA-LCD phantoms with a range of diameters matching the mean effective diameters of pediatric patients ranging from newborns to 18 years old. These phantoms were used in simulating CT images that were then inputs for a DL denoiser to evaluate performance in different sized patients. Adult CT test images were simulated using standard-sized phantoms scanned with adult scan protocols. Pediatric CT test images were simulated with pediatric-sized phantoms and adjusted pediatric protocols. The framework's evaluation methodology consisted of denoising both adult and pediatric test images then assessing changes in image quality, including noise, image sharpness, CT number accuracy, and low contrast detectability. To demonstrate the use of the framework, a REDCNN denoising model trained on adult patient images was evaluated. To validate that the DL model performance measured with the proposed pediatric IQ phantoms was representative of performance in more realistic patient anatomy, anthropomorphic pediatric XCAT phantoms of the same age range were also used to compare noise reduction performance. RESULTS: Using the proposed pediatric-sized IQ phantom framework, size differences between adult and pediatric-sized phantoms were observed to substantially influence the adult trained DL denoising model's performance. When applied to adult images, the DL model achieved a 60% reduction in noise standard deviation without substantial loss in sharpness in mid or high spatial frequencies. However, in smaller phantoms the denoising performance dropped due to different image noise textures resulting from the smaller field of view (FOV) between adult and pediatric protocols. In the validation study, noise reduction trends in the pediatric-sized IQ phantoms were found to be consistent with those found in anthropomorphic phantoms. CONCLUSION: We developed a framework of using pediatric-sized IQ phantoms for pediatric subgroup evaluation of DL denoising models. Using the framework, we found the performance of an adult trained DL denoiser did not generalize well in the smaller diameter phantoms corresponding to younger pediatric patient sizes. Our work suggests noise texture differences from FOV changes between adult and pediatric protocols can contribute to poor generalizability in DL denoising and that the proposed framework is an effective means to identify these performance disparities for a given model.

MCGPU-PET: An Open-Source Real-Time Monte Carlo PET Simulator.

Monte Carlo (MC) simulations are commonly used to model the emission, transmission, and/or detection of radiation in Positron Emission Tomography (PET). In this work, we introduce a new open-source MC software for PET simulation, MCGPU-PET, which has been designed to fully exploit the computing capabilities of modern GPUs to simulate the acquisition of more than 100 million coincidences per second from voxelized sources and material distributions. The new simulator is an extension of the PENELOPE-based MCGPU code previously used in cone-beam CT and mammography applications. We validated the accuracy of the accelerated code by comparing it to GATE and PeneloPET simulations achieving an agreement within 10 percent approximately. As an example application of the code for fast estimation of PET coincidences, a scan of the NEMA IQ phantom was simulated. A fully 3D sinogram with 6382 million true coincidences and 731 million scatter coincidences was generated in 54 seconds in one GPU. MCGPU-PET provides an estimation of true and scatter coincidences and spurious background (for positron-gamma emitters such as 124I) at a rate 3 orders of magnitude faster than CPU-based MC simulators. This significant speed-up enables the use of the code for accurate scatter and prompt-gamma background estimations within an iterative image reconstruction process.

PyMCGPU-IR Monte Carlo code test for occupational dosimetry.

PyMCGPU-IR is an innovative occupational dose monitoring tool for interventional radiology procedures. It reads the radiation data from the Radiation Dose Structured Report of the procedure and combines this information with the position of the monitored worker recorded using a 3D camera system. This information is used as an input file for the fast Monte Carlo radiation transport code MCGPU-IR in order to assess the organ doses, Hp(10) and Hp(0.07), as well as the effective dose. In this study, Hp(10) measurements of the first operator during an endovascular aortic aneurysm repair procedure and a coronary angiography using a ceiling suspended shield are compared to PyMCGPU-IR calculations. Differences in the two reported examples are found to be within 15%, which is considered as being very satisfactory. The study highlights the promising advantages of PyMCGPU-IR, although there are still several improvements that need to be implemented before its final clinical use.

Computational models of direct and indirect X-ray breast imaging detectors for in silico trials.

BACKGROUND: To facilitate in silico studies that investigate digital mammography (DM) and breast tomosynthesis (DBT), models replicating the variety in imaging performance of the DM and DBT systems, observed across manufacturers are needed. PURPOSE: The main purpose of this work is to develop generic physics models for direct and indirect detector technology used in commercially available systems, with the goal of making them available open source to manufacturers to further tweak and develop the exact in silico replicas of their systems. METHODS: We recently reported on an in silico version of the SIEMENS Mammomat Inspiration DM/DBT system using an open-source GPU-accelerated Monte Carlo x-ray imaging simulation code (MC-GPU). We build on the previous version of the MC-GPU codes to mimic the imaging performances of two other Food and Drug Administration (FDA)-approved DM/DBT systems, such as Hologic Selenia Dimensions (HSD) and the General Electric Senographe Pristina (GSP) systems. In this work, we developed a hybrid technique to model the optical spread and signal crosstalk observed in the GSP and HSD systems. MC simulations are used to track each x-ray photon till its first interaction within the x-ray detector. On the other hand, the signal spread in the x-ray detectors is modeled using previously developed analytical equations. This approach allows us to preserve the modeling accuracy offered by MC methods in the patient body, while speeding up secondary carrier transport (either electron-hole pairs or optical photons) using analytical equations in the detector. The analytical optical spread model for the indirect detector includes the depth-dependent spread and collection of optical photons and relies on a pre-computed set of point response functions that describe the optical spread as a function of depth. To understand the capabilities of the computational x-ray detector models, we compared image quality metrics like modulation transfer function (MTF), normalized noise power spectrum (NNPS), and detective quantum efficiency (DQE), simulated with our models against measured data. Please note that the purpose of these comparisons with measured data would be to gauge if the model developed as part of this work could replicate commercially used direct and indirect technology in general and not to achieve perfect fits with measured data. RESULTS: We found that the simulated image quality metrics such as MTF, NNPS, and DQE were in reasonable agreement with experimental data. To demonstrate the imaging performance of the three DM/DBT systems, we integrated the detector models with the VICTRE pipeline and simulated DM images of a fatty breast model containing a spiculated mass and a calcium oxalate cluster. In general, we found that the images generated using the indirect model appeared more blurred with a different noise texture and contrast as compared to the systems with direct detectors. CONCLUSIONS: We have presented computational models of three commercially available FDA-approved DM/DBT systems, which implement both direct and indirect detector technology. The updated versions of the MC-GPU codes that can be used to replicate three systems are available in open source format through GitHub.

Development of metaverse for intelligent healthcare.

The metaverse integrates physical and virtual realities, enabling humans and their avatars to interact in an environment supported by technologies such as high-speed internet, virtual reality, augmented reality, mixed and extended reality, blockchain, digital twins and artificial intelligence (AI), all enriched by effectively unlimited data. The metaverse recently emerged as social media and entertainment platforms, but extension to healthcare could have a profound impact on clinical practice and human health. As a group of academic, industrial, clinical and regulatory researchers, we identify unique opportunities for metaverse approaches in the healthcare domain. A metaverse of 'medical technology and AI' (MeTAI) can facilitate the development, prototyping, evaluation, regulation, translation and refinement of AI-based medical practice, especially medical imaging-guided diagnosis and therapy. Here, we present metaverse use cases, including virtual comparative scanning, raw data sharing, augmented regulatory science and metaversed medical intervention. We discuss relevant issues on the ecosystem of the MeTAI metaverse including privacy, security and disparity. We also identify specific action items for coordinated efforts to build the MeTAI metaverse for improved healthcare quality, accessibility, cost-effectiveness and patient satisfaction.

Method to measure the size of a radiographic field larger than a detector by imaging fluorescence X-rays with a slit camera.

PURPOSE: X-ray imaging devices contain a collimator system that defines a rectangular irradiation field on the detector plane. The size and position of the X-ray field, and its congruence with the corresponding light field, must be regularly tested for quality control. We propose a new method to estimate how far the x-ray field extends beyond the detector which does not require the use of external detectors. METHODS: A metallic foil is inserted perpendicularly between the source and the detector. A slit camera, a linear extension of a pinhole camera, is used to project onto the detector the fluorescence X-rays emitted by the irradiated foil. The location where the fluorescence signal inside the camera vanishes is used to extrapolate the location of the field boundary. Monte Carlo simulations were performed to determine the optimal composition and thickness of the foil. A prototype camera with a 1-mm-wide slit was built and tested in a clinical mammography and digital breast tomosynthesis (DBT) system. RESULTS: The simulations estimated that a foil made of 25 µm of Molybdenum provided the maximum signal inside the camera for a 39 kVp beam. The boundary of the X-ray fields in mammography and DBT views were experimentally measured. With the camera along the chest wall side, the measured field in multiple DBT views had a variability of only 0.4 ± 0.1 mm compared to mammography. A difference in the measured boundary position of 2.4 and -1.0 mm was observed when comparing to measurements with a fluorescent ruler and self-developing film. CONCLUSION: The introduced technique provides a practical alternative method to detect the boundary of an X-ray field. The method can be combined with other testing methods to assess the congruence of the X-rays and light fields, and to determine if the X-ray field extends beyond the detector more than permitted.

Exploring CNN potential in discriminating benign and malignant calcifications in conventional and dual-energy FFDM: simulations and experimental observations.

Purpose: Deep convolutional neural networks (CNN) have demonstrated impressive success in various image classification tasks. We investigated the use of CNNs to distinguish between benign and malignant microcalcifications, using either conventional or dual-energy mammography x-ray images. The two kinds of calcifications, known as type-I (calcium oxalate crystals) and type-II (calcium phosphate aggregations), have different attenuation properties in the mammographic energy range. However, variations in microcalcification shape, size, and density as well as compressed breast thickness and breast tissue background make this a challenging discrimination task for the human visual system. Approach: Simulations (conventional and dual-energy mammography) and phantom experiments (conventional mammography only) were conducted using the range of breast thicknesses and randomly shaped microcalcifications. The off-the-shelf Resnet-18 CNN was trained on the regions of interest with calcification clusters of the two kinds. Results: Both Monte Carlo simulations and experimental phantom data suggest that deep neural networks can be trained to separate the two classes of calcifications with high accuracy, using dual-energy mammograms. Conclusions: Our work shows the encouraging results of using the CNNs for non-invasive testing for type-I and type-II microcalcifications and may stimulate further research in this area with expanding presence of the novel breast imaging modalities like dual-energy mammography or systems using photon-counting detectors.

Using convolutional neural networks to discriminate between cysts and masses in Monte Carlo-simulated dual-energy mammography.

PURPOSE: A substantial percentage of recalls (up to 20%) in screening mammography is attributed to extended round lesions. Benign fluid-filled breast cysts often appear similar to solid tumors in conventional mammograms. Spectral imaging (dual-energy or photon-counting mammography) has been shown to discriminate between cysts and solid masses with clinically acceptable accuracy. This work explores the feasibility of using convolutional neural networks (CNNs) for this task. METHODS: A series of Monte Carlo experiments was conducted with digital breast phantoms and embedded synthetic lesions to produce realistic dual-energy images of both lesion types. We considered such factors as nonuniform anthropomorphic background, size of the mass, breast compression thickness, and variability in lesion x-ray attenuation. These data then were used to train a deep neural network (ResNet-18) to learn the differences in x-ray attenuation of cysts and masses. RESULTS: Our simulation results showed that the CNN-based classifier could reliably discriminate between cystic and solid mass round lesions in dual-energy images with an area under the receiver operating characteristic curve (ROC AUC) of 0.98 or greater. CONCLUSIONS: The proposed approach showed promising performance and ease of implementation, and could be applied to novel photon-counting detector-based spectral mammography systems.

A Review of Doses for Dental Imaging in 2010-2020 and Development of a Web Dose Calculator.

Dental imaging is one of the most common types of diagnostic radiological procedures in modern medicine. We introduce a comprehensive table of organ doses received by patients in dental imaging procedures extracted from literature and a new web application to visualize the summarized dose information. We analyzed articles, published after 2010, from PubMed on organ and effective doses delivered by dental imaging procedures, including intraoral radiography, panoramic radiography, and cone-beam computed tomography (CBCT), and summarized doses by dosimetry method, machine model, patient age, and technical parameters. Mean effective doses delivered by intraoral, 1.32 (0.60-2.56) µSv, and panoramic, 17.93 (3.47-75.00) µSv, procedures were found to be about1% and 15% of that delivered by CBCT, 121.09 (17.10-392.20) µSv, respectively. In CBCT imaging, child phantoms received about 29% more effective dose than the adult phantoms received. The effective dose of a large field of view (FOV) (>150 cm2) was about 1.6 times greater than that of a small FOV (<50 cm2). The maximum CBCT effective dose with a large FOV for children, 392.2 µSv, was about 13% of theeffective dose that a person receives on average every year from natural radiation, 3110 µSv. Monte Carlo simulations of representative cases of the three dental imaging procedures were then conducted to estimate and visualize the dose distribution within the head. The user-friendly interactive web application (available at http://dentaldose.org) receives user input, such as the number of intraoral radiographs taken, and displays total organ and effective doses, dose distribution maps, and a comparison with other medical and natural sources of radiation. The web dose calculator provides a practical resource for patients interested in understanding the radiation doses delivered by dental imaging procedures.

Computational reader design and statistical performance evaluation of an in-silico imaging clinical trial comparing digital breast tomosynthesis with full-field digital mammography.

A recent study reported on an in-silico imaging trial that evaluated the performance of digital breast tomosynthesis (DBT) as a replacement for full-field digital mammography (FFDM) for breast cancer screening. In this in-silico trial, the whole imaging chain was simulated, including the breast phantom generation, the x-ray transport process, and computational readers for image interpretation. We focus on the design and performance characteristics of the computational reader in the above-mentioned trial. Location-known lesion (spiculated mass and clustered microcalcifications) detection tasks were used to evaluate the imaging system performance. The computational readers were designed based on the mechanism of a channelized Hotelling observer (CHO), and the reader models were selected to trend human performance. Parameters were tuned to ensure stable lesion detectability. A convolutional CHO that can adapt a round channel function to irregular lesion shapes was compared with the original CHO and was found to be suitable for detecting clustered microcalcifications but was less optimal in detecting spiculated masses. A three-dimensional CHO that operated on the multiple slices was compared with a two-dimensional (2-D) CHO that operated on three versions of 2-D slabs converted from the multiple slices and was found to be optimal in detecting lesions in DBT. Multireader multicase reader output analysis was used to analyze the performance difference between FFDM and DBT for various breast and lesion types. The results showed that DBT was more beneficial in detecting masses than detecting clustered microcalcifications compared with FFDM, consistent with the finding in a clinical imaging trial. Statistical uncertainty smaller than 0.01 standard error for the estimated performance differences was achieved with a dataset containing approximately 3000 breast phantoms. The computational reader design methodology presented provides evidence that model observers can be useful in-silico tools for supporting the performance comparison of breast imaging systems.

Evaluation of data augmentation via synthetic images for improved breast mass detection on mammograms using deep learning.

We evaluated whether using synthetic mammograms for training data augmentation may reduce the effects of overfitting and increase the performance of a deep learning algorithm for breast mass detection. Synthetic mammograms were generated using in silico procedural analytic breast and breast mass modeling algorithms followed by simulated x-ray projections of the breast models into mammographic images. In silico breast phantoms containing masses were modeled across the four BI-RADS breast density categories, and the masses were modeled with different sizes, shapes, and margins. A Monte Carlo-based x-ray transport simulation code, MC-GPU, was used to project the three-dimensional phantoms into realistic synthetic mammograms. 2000 mammograms with 2522 masses were generated to augment a real data set during training. From the Curated Breast Imaging Subset of the Digital Database for Screening Mammography (CBIS-DDSM) data set, we used 1111 mammograms (1198 masses) for training, 120 mammograms (120 masses) for validation, and 361 mammograms (378 masses) for testing. We used faster R-CNN for our deep learning network with pretraining from ImageNet using the Resnet-101 architecture. We compared the detection performance when the network was trained using different percentages of the real CBIS-DDSM training set (100%, 50%, and 25%), and when these subsets of the training set were augmented with 250, 500, 1000, and 2000 synthetic mammograms. Free-response receiver operating characteristic (FROC) analysis was performed to compare performance with and without the synthetic mammograms. We generally observed an improved test FROC curve when training with the synthetic images compared to training without them, and the amount of improvement depended on the number of real and synthetic images used in training. Our study shows that enlarging the training data with synthetic samples can increase the performance of deep learning systems.

Technical Note: In silico imaging tools from the VICTRE clinical trial.

PURPOSE: In silico imaging clinical trials are emerging alternative sources of evidence for regulatory evaluation and are typically cheaper and faster than human trials. In this Note, we describe the set of in silico imaging software tools used in the VICTRE (Virtual Clinical Trial for Regulatory Evaluation) which replicated a traditional trial using a computational pipeline. MATERIALS AND METHODS: We describe a complete imaging clinical trial software package for comparing two breast imaging modalities (digital mammography and digital breast tomosynthesis). First, digital breast models were developed based on procedural generation techniques for normal anatomy. Second, lesions were inserted in a subset of breast models. The breasts were imaged using GPU-accelerated Monte Carlo transport methods and read using image interpretation models for the presence of lesions. All in silico components were assembled into a computational pipeline. The VICTRE images were made available in DICOM format for ease of use and visualization. RESULTS: We describe an open-source collection of in silico tools for running imaging clinical trials. All tools and source codes have been made freely available. CONCLUSION: The open-source tools distributed as part of the VICTRE project facilitate the design and execution of other in silico imaging clinical trials. The entire pipeline can be run as a complete imaging chain, modified to match needs of other trial designs, or used as independent components to build additional pipelines.

Dosimetric impact of voxel resolutions of computational human phantoms for external photon exposure.

Several research teams have developed computational phantoms in polygonal-mesh (PM) and/or Non-Uniform Rational B-Spline format, but it has not been systematically evaluated if the existing voxel phantoms are still dosimetrically valid. We created three voxel phantoms with the resolutions of 1,000, 125, and 1 mm3 and simulated the irradiation in antero-posterior geometry with photons of 0.1, 1, and 10 MeV using voxel Monte Carlo codes, and compared the energy deposition to their organs/tissues with the values from the original PM phantom using mesh Monte Carlo codes. The coefficient of variation in energy deposition overall showed about five-fold decrease as the voxel resolution increased but differences were mostly less than 5% for any voxel resolution. We conclude that PM phantoms and mesh Monte Carlo techniques may not be necessary for external photon exposure (0.1 - 10 MeV) and the existing voxel phantoms can provide enough dosimetric accuracy in those exposure conditions.

Reproducing two-dimensional mammograms with three-dimensional printed phantoms.

Mammography is currently the standard imaging modality used to screen women for breast abnormalities, and, as a result, it is a tool of great importance for the early detection of breast cancer. Physical phantoms are commonly used as surrogates of breast tissue to evaluate some aspects of the performance of mammography systems. However, most phantoms do not reproduce the anatomic heterogeneity of real breasts. New fabrication technologies, such as three-dimensional (3-D) printing, have created the opportunity to build more complex, anatomically realistic breast phantoms that could potentially assist in the evaluation of mammography systems. The reproducibility and relative low cost of 3-D printed objects might also enable the development of collections of representative patient models that could be used to assess the effect of anatomical variability on system performance, hence making bench testing studies a step closer to clinical trials. The primary objective of this work is to present a simple, easily reproducible methodology to design and print 3-D objects that replicate the attenuation profile observed in real two-dimensional mammograms. The secondary objective is to evaluate the capabilities and limitations of the competing 3-D printing technologies and characterize the x-ray properties of the different materials they use. Printable phantoms can be created using the open-source code introduced, which processes a raw mammography image to estimate the amount of x-ray attenuation at each pixel, and outputs a triangle mesh object that encodes the observed attenuation map. The conversion from the observed pixel gray value to a column of printed material with equivalent attenuation requires certain assumptions and knowledge of multiple imaging system parameters, such as x-ray energy spectrum, source-to-object distance, compressed breast thickness, and average breast material attenuation. To validate the proposed methodology, x-ray projections of printed phantoms were acquired with a clinical mammography system. The quality of the printing process was evaluated by comparing the mammograms of the printed phantoms and the original mammograms used to create the phantoms. The structural similarity index and the root-mean-square error were used as objective metrics to compare the two images. A detailed description of the software, a characterization of the printed materials using x-ray spectroscopy, and an evaluation of the realism of the sample printed phantoms are presented.

Feasibility of estimating volumetric breast density from mammographic x-ray spectra using a cadmium telluride photon-counting detector.

PURPOSE: Mammographic density of glandular breast tissue has a masking effect that can reduce lesion detection accuracy and is also a strong risk factor for breast cancer. Therefore, accurate quantitative estimation of breast density is clinically important. In this study, we investigate experimentally the feasibility of quantifying volumetric breast density with spectral mammography using a CdTe-based photon-counting detector. METHODS: To demonstrate proof-of-principle, this study was carried out using the single pixel Amptek XR-100T-CdTe detector. The total number of x rays recorded by the detector from a single pencil-beam projection through 50%/50% of adipose/glandular mass fraction-equivalent phantoms was measured. Material decomposition assuming two, four, and eight energy bins was then applied to characterize the inspected phantom into adipose and glandular using log-likelihood estimation, taking into account the polychromatic source, the detector response function, and the energy-dependent attenuation. RESULTS: Measurement tests were carried out for different doses, kVp settings, and different breast sizes. For dose of 1 mGy and above, the percent relative root mean square (RMS) errors of the estimated breast density was measured below 7% for all three phantom studies. It was also observed that some decrease in RMS errors was achieved using eight energy bins. For 3 and 4 cm thick phantoms, performance at 40 and 45 kVp showed similar performance. However, it was observed that 45 kVp showed better performance for a phantom thickness of 6 cm at low dose levels due to increased statistical variation at lower photon count levels with 40 kVp. CONCLUSION: The results of the current study suggest that photon-counting spectral mammography systems using CdTe detectors have the potential to be used for accurate quantification of volumetric breast density on a pixel-to-pixel basis, with an RMS error of less than 7%.

Stable gelatin-based phantom materials with tunable x-ray attenuation properties and 3D printability for x-ray imaging.

We report a novel method for developing gelatin-based phantom materials for transmission x-ray imaging with high stability at room temperature and tunable x-ray attenuation properties. This is achieved by efficiently cross-linking gelatin in a glycerin solution with only 10% water by volume and systematically decreasing their x-ray attenuation coefficients by doping with microbubbles that are originally designed to be used as lightweight additives for paints and crack fillers. For demonstration, we mimic breast glandular and adipose tissues by using such gelatin materials and also study the feasibility of 3D printing them based on the extrusion-based technique. Results from x-ray spectroscopy (15-45 keV) show the materials to have stable x-ray attenuation properties of glandular and adipose tissues over a period of two months. Micro-CT analysis of independently prepared samples shows the materials to be uniform and easy to reproduce with minimum variability in attenuation values. These materials can be used to 3D print realistic phantoms that mimic x-ray properties of various biological tissues.

Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial.

Importance: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Simulation is increasingly being used in product development but rarely in regulatory applications. Objectives: To conduct a computer-simulated imaging trial evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM) and to compare the results with a comparative clinical trial. Design, Setting, and Participants: The simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) trial was designed to replicate a clinical trial that used human patients and radiologists. Images obtained with in silico versions of DM and DBT systems via fast Monte Carlo x-ray transport were interpreted by a computational reader detecting the presence of lesions. A total of 2986 synthetic image-based virtual patients with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm were generated using an analytic approach in which anatomical structures are randomly created within a predefined breast volume and compressed in the craniocaudal orientation. A positive cohort contained a digitally inserted microcalcification cluster or spiculated mass. Main Outcomes and Measures: The trial end point was the difference in area under the receiver operating characteristic curve between modalities for lesion detection. The trial was sized for an SE of 0.01 in the change in area under the curve (AUC), half the uncertainty in the comparative clinical trial. Results: In this trial, computational readers analyzed 31 055 DM and 27 960 DBT cases from 2986 virtual patients with the following Breast Imaging Reporting and Data System densities: 286 (9.6%) extremely dense, 1200 (40.2%) heterogeneously dense, 1200 (40.2%) scattered fibroglandular densities, and 300 (10.0%) almost entirely fat. The mean (SE) change in AUC was 0.0587 (0.0062) (P < .001) in favor of DBT. The change in AUC was larger for masses (mean [SE], 0.0903 [0.008]) than for calcifications (mean [SE], 0.0268 [0.004]), which was consistent with the findings of the comparative trial (mean [SE], 0.065 [0.017] for masses and -0.047 [0.032] for calcifications). Conclusions and Relevance: The results of the simulated VICTRE trial are consistent with the performance seen in the comparative trial. While further research is needed to assess the generalizability of these findings, in silico imaging trials represent a viable source of regulatory evidence for imaging devices.

A novel physical anthropomorphic breast phantom for 2D and 3D x-ray imaging.

PURPOSE: Physical phantoms are central to the evaluation of 2D and 3D breast-imaging systems. Currently, available physical phantoms have limitations including unrealistic uniform background structure, large expense, or excessive fabrication time. The purpose of this work is to outline a method for rapidly creating realistic, inexpensive physical anthropomorphic phantoms for use in full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT). METHODS: The phantom was first modeled using analytical expressions and then discretized into voxels of a specified size. The interior of the breast was divided into glandular and adipose tissue classes using Voronoi segmentation, and additional structures like blood vessels, chest muscle, and ligaments were added. The physical phantom was then fabricated from the virtual model in a slice by slice fashion through inkjet printing, using parchment paper and a radiopaque ink containing 33% (I33% ) or 25% (I25% ) iohexol by volume. Three types of parchment paper (P1, P2, and P3) were examined. The phantom materials were characterized in terms of their effective linear attenuation coefficients (µeff ) using full-field digital mammography (FFDM) and their energy-dependent linear attenuation coefficients (µ(E)) using a spectroscopic energy discriminating detector system. The printing method was further validated on the basis of accuracy, print consistency, and the reproducibility of ink batches. RESULTS: The µeff of two types of parchment paper were close to that of adipose tissue, with µeff = 0.61 ± 0.05 cm-1 for P1, 0.61 ± 0.04 cm-1 for P2, and 0.57 ± 0.03 cm-1 for adipose tissue. The addition of the iodinated ink increased the effective attenuation to that of glandular tissue, with µeff = 0.89 ± 0.06 cm-1 for P1 + I25% and 0.94 ± 0.06 cm-1 for P1 + I33% compared to 0.90 ± 0.03 cm-1 for glandular tissue. Spectroscopic measurements showed a good match between the parchment paper and reference values for adipose and glandular tissues across photon energies. Good accuracy was found between the model and the printed phantom by comparing a FFDM of the virtual model simulated through Monte Carlo with a real FFDM of the fully printed phantom. High consistency was found over multiple prints, with 3% variability in mean ink signal across various samples. Reproducibility of ink consistency was very high with <1% variation signal from multiple batches of ink. Imaging of the phantom using FFDM and DBT systems showed promising utility for 2D and 3D imaging. CONCLUSIONS: A novel, realistic breast phantom can be created using an analytically defined breast model and readily available materials. The work provides a method to fabricate any virtual phantom in a manner that is accurate, inexpensive, easily accessible, and can be made with different materials or breast models.

Maximum-likelihood estimation of scatter components algorithm for x-ray coherent scatter computed tomography of the breast.

Coherent scatter computed tomography (CSCT) is a reconstructive x-ray imaging technique that yields the spatially resolved coherent-scatter cross section of the investigated object revealing structural information of tissue under investigation. In the original CSCT proposals the reconstruction of images from coherently scattered x-rays is done at each scattering angle separately using analytic reconstruction. In this work we develop a maximum likelihood estimation of scatter components algorithm (ML-ESCA) that iteratively reconstructs images using a few material component basis functions from coherent scatter projection data. The proposed algorithm combines the measured scatter data at different angles into one reconstruction equation with only a few component images. Also, it accounts for data acquisition statistics and physics, modeling effects such as polychromatic energy spectrum and detector response function. We test the algorithm with simulated projection data obtained with a pencil beam setup using a new version of MC-GPU code, a Graphical Processing Unit version of PENELOPE Monte Carlo particle transport simulation code, that incorporates an improved model of x-ray coherent scattering using experimentally measured molecular interference functions. The results obtained for breast imaging phantoms using adipose and glandular tissue cross sections show that the new algorithm can separate imaging data into basic adipose and water components at radiation doses comparable with Breast Computed Tomography. Simulation results also show the potential for imaging microcalcifications. Overall, the component images obtained with ML-ESCA algorithm have a less noisy appearance than the images obtained with the conventional filtered back projection algorithm for each individual scattering angle. An optimization study for x-ray energy range selection for breast CSCT is also presented.

Monte Carlo reference data sets for imaging research: Executive summary of the report of AAPM Research Committee Task Group 195.

The use of Monte Carlo simulations in diagnostic medical imaging research is widespread due to its flexibility and ability to estimate quantities that are challenging to measure empirically. However, any new Monte Carlo simulation code needs to be validated before it can be used reliably. The type and degree of validation required depends on the goals of the research project, but, typically, such validation involves either comparison of simulation results to physical measurements or to previously published results obtained with established Monte Carlo codes. The former is complicated due to nuances of experimental conditions and uncertainty, while the latter is challenging due to typical graphical presentation and lack of simulation details in previous publications. In addition, entering the field of Monte Carlo simulations in general involves a steep learning curve. It is not a simple task to learn how to program and interpret a Monte Carlo simulation, even when using one of the publicly available code packages. This Task Group report provides a common reference for benchmarking Monte Carlo simulations across a range of Monte Carlo codes and simulation scenarios. In the report, all simulation conditions are provided for six different Monte Carlo simulation cases that involve common x-ray based imaging research areas. The results obtained for the six cases using four publicly available Monte Carlo software packages are included in tabular form. In addition to a full description of all simulation conditions and results, a discussion and comparison of results among the Monte Carlo packages and the lessons learned during the compilation of these results are included. This abridged version of the report includes only an introductory description of the six cases and a brief example of the results of one of the cases. This work provides an investigator the necessary information to benchmark his/her Monte Carlo simulation software against the reference cases included here before performing his/her own novel research. In addition, an investigator entering the field of Monte Carlo simulations can use these descriptions and results as a self-teaching tool to ensure that he/she is able to perform a specific simulation correctly. Finally, educators can assign these cases as learning projects as part of course objectives or training programs.